Centres of Excellence for Regulatory Science and Innovation (Grant)

About this opportunity

Word limit: 550In plain English, provide a summary we can use to identify the most suitable experts to assess your application. We usually make this summary publicly available on external-facing websites, therefore do not include any confidential or sensitive information. Make it suitable for a variety of readers, for example: opinion-formers policymakers the public the wider research community Guidance for writing a summary Clearly describe your proposed work in terms of: context the challenge the project addresses aims and objectives potential applications and benefits Core team List the key members of your team and assign them roles from the following: project lead (PL) project co-lead (UK) (PcL) project co-lead (international) (PcL (I)) specialist grant manager professional enabling staff research and innovation associate technician visiting researcher researcher co-lead (RcL) Only list one individual as project lead. If you include more than one project lead your application will fail at the checking stage.UKRI has introduced a new addition to the ‘Specialist’ role type. Public contributors such as people with lived experience can now be added to an application. Find out more about UKRI’s core team roles in funding applications . Application questions Vision Word limit: 1,000What are you hoping to achieve with your proposed work? What the assessors are looking for in your response Explain how your proposed work: is of excellent quality and importance within or beyond the field(s) or area(s) has the potential to advance current understanding, or generate new knowledge, thinking or discovery within or beyond the field or area is timely given current trends, context, and needs Within the Vision section we also expect you to: advance current understanding, or generate new knowledge, methods, tools, standards, approaches or thinking, within a chosen field or area of regulatory science articulate the regulatory science challenge(s) the proposed CERSI will address and explain their significance explain how the proposed CERSI aligns with one of the strategic themes set out in this funding opportunity explain the potential for the work to inform regulatory policy, practice, guidance, methodologies or decision-making We also expect you to demonstrate the ambition, coherence and added value of the proposed CERSI as a Centre of Excellence, describing how it will: bring together the critical mass of expertise needed to address the identified regulatory science challenge(s) build effective partnerships with industry and other relevant stakeholders Ensure you explain how the proposed work will generate regulatory science: knowledge evidence methods tools standards or approaches These must have potential for broad applicability, enabling innovation in the development and regulation of healthcare products. You are also required to identify the potential direct and indirect benefits of the proposed CERSI and who the beneficiaries might be, including: potential benefits to patients and the public the health system the life sciences sector and the wider regulatory science ecosystem References may be included within this section. You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service. Approach Word limit: 3,500How are you going to deliver your proposed work? What the assessors are looking for in your response Explain how you have designed your approach so that it: is effective and appropriate to achieve your objectives uses a clearly written and transparent methodology (if applicable) summarises the previous work and describes how this will be built upon and progressed (if applicable) will maximise translation of outputs into outcomes and impacts describes how your, and if applicable your team’s, research environment (in terms of the place and relevance to the project) will contribute to the success of the work Within the Approach section we also expect you to: describe your approach to the proposed programme of research. You should describe how its component work packages or activities form a coherent programme, addresses the CERSI’s overall vision, aim and objectives provide your CERSI programme plan including key milestones, dependencies and timelines, in the form of an embedded Gantt chart or similar demonstrate access to the appropriate services, facilities, infrastructure, or equipment to deliver the CERSI programme where relevant, explain how cross-cutting regulatory science considerations identified in the funding opportunity inform the proposed programme of work if applicable, explain and justify how you will approach diversity and inclusion in the study population and follow the MRC embedding diversity in research design policy demonstrate that the proposed CERSI programme of work is appropriately focused and achievable within the timeframe, scope and resources of the award show how you will use male and female animals or tissues and cells from female and male donors, if applicable, in your research. If you are not proposing to do this justify why, if applicable describe your approach to ethical and regulatory approvals and their status. Consider the MRC guidance on ethics and approvals explain and justify any involvement of human participants, including participant numbers, characteristics, recruitment methods, the procedures to be undertaken, and their severity explain and justify any use of human tissues or biological samples, including the type of material to be used, quantity required, and its source You should also ensure you justify and describe how you will engage with relevant stakeholders and the added value their involvement will bring, including: regulators patients and public partnerships healthcare professionals industry and other end users (as appropriate) devolved administrations and local regions throughout the development, delivery and translation of the CERSI This must include how you plan to develop partnerships with industry and other relevant stakeholders to maximise outputs and impact. You must explain how the CERSI will contribute to developing sustainable UK regulatory science capacity and capability, including through: skills development training knowledge exchange any other relevant and appropriate activities References may be included within this section. You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service. Leadership, governance and agility Word limit: 1,000How will leadership and governance be organised in the CERSI to enable effective programme delivery and be sufficiently adaptable to respond to evolving regulatory science needs? What the assessors are looking for in your response Explain how the proposed CERSI will: be effectively and inclusively led and managed, with clear systems, structures, roles, responsibilities, oversight and accountability for programme delivery establish and implement effective governance and decision-making arrangements across collaborating disciplines and organisations work collaboratively with MHRA and the CERSI programme’s oversight structure to maintain alignment with current regulatory science needs maintain awareness of emerging scientific and technological developments relevant to the CERSI and identify their implications for regulatory science identify and prioritise activities, including the processes and criteria for initiating, adapting or discontinuing work where appropriate monitor progress against agreed milestones, deliverables and intended outcomes, and manage risks or underperformance maintain sufficient flexibility in programme management and decision-making arrangements to respond to new priorities while retaining coherence with the overall CERSI vision, aims and objectives Reproducibility and statistical design Word limit: 500How will you ensure your proposed work is reliable, robust and reproducible? What assessors are looking for in your response Provide information about reproducibility and how you will ensure reliability and robustness of the research, methods, tools, models, frameworks or evidence approaches developed or evaluated through your CERSI programme, such as: further details of statistical analyses methodology validation experimental design These should be appropriate to the proposed regulatory science, not provided in your approach. We expect you to seek professional statistical or other relevant methodological advice, where appropriate. Depending on the nature of the proposed work your response should include, as appropriate: methods for assessing the validity, reliability, robustness and reproducibility of proposed approaches validation and evaluation approaches, including appropriate comparators, benchmarks or performance criteria where relevant sample and effect sizes, where applicable planned statistical analyses, where applicable models chosen (for example animal model, cell lines, computational or analytical models) potential sources of bias and how these will be mitigated during analysis generalisability and applicability across relevant populations, settings, data sources or regulatory contexts, where appropriate how your approach to addressing diversity is reflected in the design, evaluation and analyses of the proposed work, where relevant Refer to the MRC guidance for applicants , for further information, examples and online tools. If your proposed work involves animals, and you provide information on animal sample sizes and statistical analyses here, you should not duplicate it in the ‘Animal involvement and ‘3Rs’’ section. Use the ‘Animal involvement and ‘3Rs’’ section to provide information on the rationale for using animals, choice of species, welfare and procedure severity. You may demonstrate elements of your responses in visual form if relevant. Further details are provided in the Funding Service. The length of your response will vary depending on the type of project,